Erlotinib for Frontline Treatment of Advanced Non–Small Cell Lung Cancer: a Phase II Study
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- Giuseppe Giaccone
- 1Medical Oncology and Departments of
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- Marielle Gallegos Ruiz
- 1Medical Oncology and Departments of
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- Thierry Le Chevalier
- 3Institut Gustave Roussy, Paris, France;
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- Nick Thatcher
- 4Christie Hospital, Manchester NHS Trust, Manchester, United Kingdom;
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- Egbert Smit
- 2Pulmonary Diseases, Vrije Universiteit Medical Center, Amsterdam, the Netherlands;
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- Jose Antonio Rodriguez
- 1Medical Oncology and Departments of
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- Pasi Janne
- 5Dana-Farber Cancer Center, Boston, Massachusetts; and
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- Dalila Oulid-Aissa
- 6Hoffmann-La Roche Ltd., Basel, Switzerland
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- Jean-Charles Soria
- 3Institut Gustave Roussy, Paris, France;
説明
<jats:title>Abstract</jats:title> <jats:p>Purpose: Erlotinib has proven activity in pretreated patients with advanced non–small cell lung cancer (NSCLC). We evaluated erlotinib in the frontline treatment of advanced NSCLC and assessed biological predictors of outcome.</jats:p> <jats:p>Experimental Design: In this phase II study, chemotherapy-naive patients with stage IIIB/IV NSCLC received oral erlotinib (150 mg/d) until disease progression or unacceptable toxicity occurred. Tumor response was assessed every 6 weeks, and samples were analyzed for potential molecular markers of treatment response and survival. The primary end point was the proportion of patients without disease progression after 6 weeks of treatment.</jats:p> <jats:p>Results: Fifty-three patients were eligible. The overall rate of nonprogression at 6 weeks was 52.8% (28 of 53 patients). Tumor response rate was 22.7%, with 1 complete response, 11 partial responses, and 16 cases of stable disease. Responses were seen across most patient clinical characteristics. The median duration of tumor response was 333 days; median overall survival was 391 days; and median time to disease progression was 84 days. Erlotinib was well tolerated, the main treatment-related adverse events being mild-to-moderate rash and diarrhea. Histologic material for biological studies was available in 29 cases. Four of five responders and one patient with stable disease had a classic epidermal growth factor receptor tyrosine kinase mutation. Two progressing patients exhibited epidermal growth factor receptor point mutations (one with T790M mutation), and K-ras mutations were detected in 10 nonresponders.</jats:p> <jats:p>Conclusions: Erlotinib shows significant antitumor activity in the first-line treatment of advanced NSCLC and may be a viable alternative to chemotherapy. Patient selection cannot easily be based on clinical or biological variables.</jats:p>
収録刊行物
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- Clinical Cancer Research
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Clinical Cancer Research 12 (20), 6049-6055, 2006-10-15
American Association for Cancer Research (AACR)
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詳細情報 詳細情報について
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- CRID
- 1362262945730599296
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- ISSN
- 15573265
- 10780432
- http://id.crossref.org/issn/10780432
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- データソース種別
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- Crossref